Nowadays, traceability matrices are used as an important tool for planning and tracking commissioning and qualification activities. However, mostly simple software tools like Excel are used for this purpose. On the one hand, this is very time and resource consuming, and on the other hand, the data cannot be reused digitally.

In order to define the scope of commissioning and qualification tests in an engineering project in a meaningful way, the risk analysis method of FMEA is usually used in the pharmaceutical industry.
By performing these risk assessments based on the URS (user requirement specifications) and by implementing the integrated commissioning and qualification (iC&Q) approach into the risk assessments, commissioning can be fully integrated into the qualification activities - to save money and time.

Automated risk assessments go beyond the planning phase. By integrating the tracking of actions, the risk assessment automatically becomes a trace matrix and the required C&Q documents can be automatically created and kept up-to-date in a central location. In addition, the status of an engineering project can be tracked at any time.